NDC 81238-5300 Aramark Antiseptic

Benzalkonium Chloride, Benzocaine

NDC Product Code 81238-5300

NDC 81238-5300-1

Package Description: 59.1 mL in 1 BOTTLE, SPRAY

NDC Product Information

Aramark Antiseptic with NDC 81238-5300 is a a human over the counter drug product labeled by Western First Aid Safety Dba Aramark. The generic name of Aramark Antiseptic is benzalkonium chloride, benzocaine. The product's dosage form is spray and is administered via topical form.

Labeler Name: Western First Aid Safety Dba Aramark

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Aramark Antiseptic Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZALKONIUM CHLORIDE 1 mg/mL
  • BENZOCAINE 50 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Western First Aid Safety Dba Aramark
Labeler Code: 81238
FDA Application Number: part333A What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-24-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Aramark Antiseptic Product Label Images

Aramark Antiseptic Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

If swallowed get medical help orcontact a Poison Contrl Center right away.

Active Ingredients

Benzalkonium Chloride 0.1%Benzocaine 5.0%

Purpose

Benzalkonium Chloride ....First aid antisepticBenzocaine .................Total pain relief

Uses

First aid to help prevent infection and for temporary painrelief in minor cuts, scrapes and burns

Warnings

For external use only.

Do Not Use

  • Near eyes or mucous membranes • on deep orpuncture wounds, animal bites, or serious burns • over large areasof the body • more than one week unless directed by a doctor

Directions

• clean affected area and spray 1 to 3 times daily• may be covered with a sterile bandage • children under 2 ask adoctor

Inactive Ingredients

Isopropyl alcohol, purified water

Package Labeling

AramarkCut & ScrapeAmtiseptic\SprayFor Temporary PainRelief and to HelpPrevent Infection inMinor Cuts, Scrapesand abrasions.2 fl. oz. (59.1ml)Reorder no. 53000MANUFACTURED FOR:AramarkLenexa, KS 66219  886-362-2691res

* Please review the disclaimer below.